OTO-201 for the Treatment of Otitis Externa

A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa

This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

Study Overview

• Status: Completed
• Conditions: Otitis Externa
• Intervention / Treatment: Drug: OTO-201 (ciprofloxacin)

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Email Otonomy Central Contact for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria includes, but is not limited to:

• Subject is a male or female aged 6 months to 80 years, inclusive
• Subject has a clinical diagnosis of unilateral otitis externa
• Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

• Subject has tympanic membrane perforation
• Subject has a history of known immunodeficiency disease
• Subject has fungal otitis externa, based on clinical signs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1 mL OTO-201; Ciprofloxacin	Drug: OTO-201 (ciprofloxacin)
Experimental: 0.2 mL OTO-201; Ciprofloxacin	Drug: OTO-201 (ciprofloxacin)
Experimental: 0.4 mL OTO-201; Ciprofloxacin	Drug: OTO-201 (ciprofloxacin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Otoscopic Examination: Tympanic Membrane	Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day)	Up to 1 month
Otoscopic Examination: Middle Ear	Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit)	Up to 1 month
Feasibility of Administration	Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy".	Day1
Overall Adverse Events	Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set)	Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3	Day 15 (two weeks from dosing)
Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set)	Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3	Day 15 (2 weeks from dosing)

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Ear infection; Otitis externa; Swimmer's ear
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 201-201506